Clareon CCW0T3 (UDI 00380652431859)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652431859), received between Dec 11, 2023 and May 26, 2026 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Break2
- Defective Device1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information3
- Blurred Vision2
- Visual Impairment2
- Visual Disturbances1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANTED A MONOFOCAL TORIC LENS AND IDENTIFIED THERE WAS A DETACHED HAPTIC WHEN PROCEEDING WITH ROTATION OF THE IOL FOR TORIC ALIGNMENT. THE OPPOSITE HAPTIC ALSO WAS TORN. THE SCRUB TECH STATED THAT THEY HAD NO RESISTANCE WHEN ADVANCING THE IOL IN THE INJECTOR.
Patient problems: Insufficient Information
MAUDE report 25278836 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT AND CLINICAL REASON AS PATIENT ENDED UP MYOPIC-POOR VISION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 24051645 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE. CLINICAL REASON WAS REPORTED TO BE AS VISUAL DISTURBANCES. THE LENS WAS REPLACED WITH OTHER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: Visual Disturbances
MAUDE report 21400839 ↗MalfunctionJan 3, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED HAPTIC WAS BROKEN, DOCTOR SAID THERE WAS A TEAR IN THE LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21069070 ↗InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HARD TIME DRIVING AT NIGHT, OUT OF FOCUS AND BLURRY. CLINICAL REASON FOR PLANNED EXPLANT REPORTED TO BE PATIENT WOULD BE MORE COMFORTABLE WITH HIS NIGHT VISION IF IT WAS TARGETING DISTANCE. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Blurred Vision
MAUDE report 19237062 ↗InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD HARD TIME SEEING WHEN READING. ACCORDING TO PATIENT, AFTER THE SURGERY, EXPECTED VISION WAS NOT ACHIEVED. THEREFORE, AN EXPLANT HAS BEEN PLANNED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18683836 ↗MalfunctionDec 11, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL FOUND TO HAVE DEFECTIVE. ADDITIONAL INFORMATION RECEIVED AND STATES THAT THE LENS HAVE BEEN REMOVED DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18300187 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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